Executive Director, Regulatory Affairs

vor 21 Stunden

Zug, Schweiz Mirati Therapeutics Inc Vollzeit

**Job Description Summary**

Reporting to the SVP and Head of International, based in Zug, and the VP Regulatory Affairs & Quality, based in San Diego, this professional will be part of both the International Leadership and the Global Regulatory Affairs Teams with responsibility for oversight of EU and International Regulatory activities to support corporate business goals. Proactively providing regulatory guidance, developing and implementing strategies to efficiently advance pipeline compounds through to commercialization and compliant post approval lifecycle management.

Collaborates closely with cross‐functional teams to ensure effective regional as well as affiliate regulatory support. Participates in senior level interactions with external partner companies, Contract Research Organization (CRO) regulatory personnel, and external vendors. Functions as primary senior regulatory representative interacting with EMA and affiliated region regulatory agencies. Helps evaluate business impact of changes in government regulatory requirements and policies and develops responses. Helps develop infrastructure and process improvements, including implementation of applicable e‐tools, to enhance the efficiency of the Regulatory Affairs Department operations. Participates in the selection and development of personnel to ensure enhancement of Regulatory Affairs function.

**Your Responsibilities**
- Responsible for managing and leading multi-disciplinary teams and/or Contract Service Providers, to achieve project and business goals per timelines
- As the Marketing Authorisation Holder representative, leads the development and reviews EU centric regulatory submissions (eg. MAA, variations, post marketing measures, PIP documents), to ensure high quality standards and regulatory requirements are met, in line with corporate objectives
- Ensures regulatory agency questions during MAA and variation reviews are responded to promptly and comprehensively to resolve issues and obtain timely regulatory approvals. Functions as senior primary regulatory representative for negotiations with EMA/MHRA and other international regulatory agencies
- Ensures coordination of Regulatory Affairs activities both at the International regional as well as local country level.
- Assesses country and regional‐specific regulations/requirements, and develops proactive regulatory plans and strategies, aligned with business goals, to expedited development of the company's proprietary products towards commercialization
- Participates in senior level interactions with external business partners to provide regulatory expertise on co‐development of products
- Oversight responsibility to help ensure compliance with EMA /MHRA/ International government regulatory requirements, International Conference on Harmonization (ICH) standards and relevant regional and/or local Codes of Conduct
- Keeps current on US and International regulatory developments and changes in government policies/ requirements to advise on impact on company projects/business and to develop appropriate response plans
- Oversight responsibility for resolving issues with regulatory impact resulting from audits of external vendors/CROs and health authority inspections.
- Helps develop the infrastructure of the Regulatory Affairs Department, including SOPs and implementation of process improvements, to enhance the efficiency of operations
- Helps manage budget and provides input into budgeting and resource requirements
- Helps select CRO regulatory consultants/personnel and manages their activities to ensure deadlines and milestones on company regulatory projects are achieved per deadlines to meet company goals
- Participates in the selection, development, management, and performance review of personnel to enhance the Regulatory Affairs functional operations

**What is Required**
- Demonstrated experience and ability to successfully interact and negotiate with senior EMA/ MHRA/ International Agency regulatory reviewers, and external vendors partners
- Broad experience in Regulatory disciplines (i.e., clinical, labeling, safety & CMC, ) is preferred
- Expert knowledge in EU/International regulations and guidance Up to date experience in Leading an EMA Filling (Oncology ideal) along with sound experience with CMA
- Experience in working within a nimble resource environment and closely with a US based Team
- Experience in building EU Regulatory Teams
- Capacity to work cross functionally, especially with Market Access and Medical Affairs/Clinical Development
- Must have effective Strategic and "hands-on" capabilities
- Excellent leadership and organizational skills plus effective written and verbal communication skills, and interpersonal skills are required; must be able to effectively use these skills to influence many diverse internal and external customer groups at various levels within organizations
- Must be experienced in staff and organizational development, motivating personnel / t

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